IPS-INTEGRATED
24.5.2023 12:06:27 CEST | Business Wire | Press release
IPS-Integrated Project Services, LLC, a leading provider of engineering, procurement, construction management, and validation (EPCMV) services, congratulates WuXi Biologics Ireland Limited (WuXi Biologics) for receiving a Facility of the Year Award (FOYA) from The International Society for Pharmaceutical Engineering (ISPE) in the Operations category for their Large-Scale Manufacturing Facility in Mullagharlin, Dundalk, Ireland. The IPS team of experts provided a range of services for the project, including process design, engineering, architecture, construction management, and validation support.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230518005360/en/
WuXi Biologics' Large-Scale Manufacturing Facility in Mullagharlin, Dundalk, Ireland. (Photo: Business Wire)
The ISPE Facility of the Year Awards (FOYA) program recognizes state-of-the-art pharmaceutical manufacturing facilities utilizing innovative design and construction strategies to produce high-quality, safe, cost-effective medicines. WuXi Biologics was recognized for its cutting-edge biologics manufacturing facility in Dundalk, Ireland. The FOYA judges found this project “an inspiring landmark that proves that facilities can be developed on a highly accelerated schedule, using innovative solutions while complying with regulatory requirements, overcoming unknown barriers, cooperation with the community, and upholding project success and product safety.”
Brendan McGrath, Vice President and Head of WuXi Biologics Ireland site, commented, "This recognition by ISPE is a testament to our team's dedication and relentless pursuit of excellence. We are also extremely grateful for the exceptional work of IPS, our facility designer, whose expertise significantly contributed to our achievement. This award signifies success not only for our team but also for our clients, partners, and local community. Ultimately, it's a victory for the patients who rely on the life-saving biologics manufactured at our Ireland site."
The WuXi Biologics facility is one of the world’s largest contract manufacturing single-use bioreactor sites. However, the facility’s real achievement is its unprecedented flexibility in cell culture-based manufacturing regardless of batch size by “scaling out” with 12 ABEC 4,000-liter capacity bioreactors. The facility’s flexible array of highly-configurable systems and overall capability to adapt to almost any perfusion, fed-batch, concentrated fed-batch, and intensified fed-batch techniques reduce client risk. This capability, combined with innovations in automation, single-use materials, and transition time, transforms the WuXi Biologics facility into a game changer for the production of emerging antibody-based therapies on a global impact.
The project was the first in Ireland to be delivered using an innovative design-assist model. IPS developed design packages to 60% detailed design; the remaining 40% was completed with engagement from the construction team, including subcontractors. This collaborative approach improved constructability, reduced time/cost, and significantly reduced rework. The single-use technology allows for a capacity of 48,000L, making it the largest single-use bioreactor in Ireland and possibly all of Europe.
The fast-track project was completed with over 6.2 million work hours in 26 months, with an average of 2,200 employed at peak. A total of 7,610 personnel were inducted on-site. Throughout construction in 2019 and 2020, more than 75 archaeologists were empowered to dig at sites spread across the campus. The artifacts found on the site depict common and extraordinary life spread across thousands of years—everything from fine sewing needles carved from bone to medieval spearheads and a cache of shiny 10th-century coins. WuXi Biologics maintained the schedule during their archaeological preservation and COVID challenges.
“IPS has been a partner to WuXi Biologics since its early days, and it is great to see it win the prestigious Facility of the Year Award. I still remember the early days of this project conception and when WuXi Biologics procured the massive site in Dundalk. Seeing the fantastic conclusion of all the efforts that followed is truly memorable. We are honored to have been part of this state-of-the-art facility which truly represents innovation, cutting-edge technology, and excellence. Congratulations to WuXi Biologics on this incredible achievement,“ said Dave Goswami, PE, IPS Chairman and Chief Executive Officer.
Cell-based therapeutics are transforming modern medicine, and WuXi Biologics’ facility is highly flexible and adaptable, ensuring the facility will have the capacity to produce a variety of new cellular therapies for years to come.
About IPS
IPS, a Berkshire Hathaway Company, is a global leader in developing innovative business solutions for the biotechnology and pharmaceutical industries. Through operational expertise and industry-leading knowledge, skill, and passion, IPS provides consultancy services, architecture, engineering, project controls, construction management, and compliance services that allow clients to develop and manufacture life-impacting products. Its newest acquisition, Linesight, specializes in cost, schedule, risk, program, and project management services in various market sectors, including data centers, life sciences, and high-tech industrial. With the addition of Linesight, IPS has over 3,000 professionals in over 45 offices across 17 countries in the Americas, Europe, Asia Pacific, Southeast Asia, Australia, and the Middle East. For further information, please visit www.ipsdb.com.
About WuXi
WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide.
With over 12,000 skilled employees in China, the United States, Ireland, Germany and Singapore, WuXi Biologics leverages its technologies and expertise to provide customers with efficient and cost-effective biologics discovery, development and manufacturing solutions. As of December 31, 2022, WuXi Biologics is supporting 588 integrated client projects, including 17 in commercial manufacturing.
WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of our ethos and business strategy, and we aim to become an ESG leader in the biologics CRDMO sector. Our facilities use next-generation biomanufacturing technologies and clean-energy sources. We have also established an ESG committee led by our CEO to steer the comprehensive ESG strategy and its implementation, enhancing our commitment to sustainability. For more information about WuXi Biologics, please visit www.wuxibiologics.com.
About the ISPE Facility of the Year Awards Program
Established in 2005, The Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches. Visit ISPE.org/FOYA for more information.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230518005360/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
International Human Rights Lawyer Jared Genser and Former White House Counsel Lanny J. Davis Join Legal and Advocacy Team Supporting Cambodian Businessman Yim Leak, Seiden Law LLP Announces18.9.2026 19:52:00 CEST | Press release
Jared Genser, one of the world's most recognized international human rights lawyers, and Lanny J. Davis, an adviser to former presidents George W. Bush and Bill Clinton, join the legal and advocacy team for Cambodian businessman Yim Leak and challenge what they call a coordinated smear campaign in Thailand. International human rights lawyer Jared Genser and Lanny J. Davis, who has close ties to two former US presidents and a worldwide reputation for defending those under attack with lies and smears, and for repairing the damage done to their reputations, have joined the legal and advocacy team supporting Cambodian businessman Yim Leak, Seiden Law LLP, which serves as Yim Leak's chief global counsel, announced today. Their first move is to hold the Thai government accountable, framing its conduct as either complicit in or willfully blind to a sustained smear campaign against Yim. Genser is Managing Director of Perseus Strategies, an international law firm. Over more than two decades, he
Ningbo FEED Meeting Confirms Full Confidence in Q1 2027 FID for Allied Biofuels’ US$6.1 Billion Presidential Decree-Backed SAF and e-SAF Project18.9.2026 17:38:00 CEST | Press release
Allied Biofuels has held a major Front-End Engineering Design (FEED) meeting at Sinopec’s office in Ningbo, China, bringing together Allied Biofuels, Sinopec Engineering Group Co., Ltd. of China, Topsoe A/S of Denmark, Sasol South Africa Limited, and Plug Power of the United States — the principal international engineering and technology providers supporting its US$6.1 billion Presidential Decree-backed Sustainable Aviation Fuel (SAF) and e-SAF project in Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260918708077/en/ FEED Meeting - Ningbo, China At the joint FEED meeting of the project’s core engineering and technology stakeholders, the discussions established clear alignment on engineering responsibilities, technology interfaces, design deliverables, project integration and the coordinated execution programme required to advance the project through FEED. All stakeholders working on the project expressed full co
Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant)18.9.2026 14:00:00 CEST | Press release
Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission (EC) should approve relacorilant, combined with the chemotherapy drug nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer. The CHMP’s recommendation is based on positive data from Corcept’s Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant combined with nab-paclitaxel experienced improved progression-free and overall survival compared to patients who received nab-paclitaxel alone. The safety profile of relacorilant plus nab-paclitaxel in these trials was consistent with the safety profile of nab-paclitaxel monoth
Enhertu® Recommended for Approval in the EU by CHMP as Adjuvant Treatment for Patients with Residual Disease After Neoadjuvant Treatment for HER2 Positive Early Breast Cancer18.9.2026 14:00:00 CEST | Press release
Recommendation based on DESTINY-Breast05 phase 3 trial results that showed Enhertu reduced the risk of invasive disease recurrence or death by 53% versus T-DM1 Daiichi Sankyo and AstraZeneca’s Enhertu has the potential to become a new standard of care in this early breast cancer setting Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the adjuvant treatment of adult patients with resected HER2 positive breast cancer who have residual invasive disease after neoadjuvant taxane-based and HER2 targeted treatment. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the DESTINY-Breast05 phase 3 trial presented at th
CHMP Recommends EU Approval of New Indication for Alfasigma’s Jyseleca® (filgotinib), Treatment of Adults With Axial Spondyloarthritis18.9.2026 12:58:00 CEST | Press release
The information contained within this press release is for the purpose of scientific exchange.It is intended for scientific, financial and investor media only.If approved, Jyselecawill be indicated for the treatment of patients with active axial spondyloarthritis (axSpA), both non-radiographic and radiographic forms of the disease, who have responded inadequately to conventional therapy.Despite the availability of multiple treatment options, nearly half of people living with axSpA do not respond adequately to current therapies, and just 10-20% reach inactive disease within 16-24 weeks of initiating treatment.CHMP’s positive opinion is based on findings from the OLINGUITO Phase 3 study, where improvements in the signs and symptoms of axSpA with filgotinib were observed early and maintained over 52 weeks of treatment.Jyselecais already approved in Europe and the United Kingdom, for the treatment of moderate to severe rheumatoid arthritis and ulcerative colitis. Alfasigma S.p.A, a global
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom
